Serologic Testing of Household Contacts of Confirmed Cases of COVID-19

Sponsor

Hospital Universitario Dr. Jose E. Gonzalez (Other)

Overall Status

Completed

CT.gov ID

NCT04393142

Collaborator

(none)

Enrollment

Location

9.4

Actual Duration (Months)

10.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

SARS-CoV-2 has now crossed the 1 million number of cases and tens of thousands of deaths. It´s R0 has been calculated between 2 and 5.7 solely based on clinical symptoms but it is estimated to likely be higher. Serologic evidence of infection has not been analyzed.

Condition or Disease	Intervention/Treatment	Phase
Coronavirus Infection

Detailed Description

Transverse, observational and descriptive study involving household contacts of documented patients with COVID-19 infection: contacts will be invited to participate and a blood sample will be drowned: IgM and IgG qualitative and quantitative measurements will be performed. Demographic data regarding age, comorbidities, calculated time spent before and after the patients diagnosis, isolation practices etc.

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

96 participants

Observational Model:

Other

Time Perspective:

Cross-Sectional

Official Title:

Observational Trial Evaluating the Serologic Status of Household Contacts of Patients Diagnosed With COVID-19

Actual Study Start Date :

May 5, 2020

Actual Primary Completion Date :

Feb 16, 2021

Actual Study Completion Date :

Feb 16, 2021

Outcome Measures

Primary Outcome Measures

Identify antibodies [1 day]
Identify the presence of IgM and IgG antibodies from intradomestic contacts of patients with Polymerase Chain Reaction for detected SARS-CoV-2 .

Secondary Outcome Measures

Determine antibody sensitivity [1 day]
Determine the sensitivity of IgM and IgG antibody detection by ELISA in direct eastern contacts of patients with PCR for detected SARS-CoV-2.
IgM determination [1 day]
Determine the presence of IgM antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.
IgG determination [1 day]
Determine the presence of IgG antibodies by ELISA in direct eastern contacts of patients with detected SARS-CoV-2 PCR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Persons over 1 years of age.
.Meet COVID-19 confirmed case intradomestic contact definition:
Living in the same home as the patient with SARS-CoV-2 PCR test detected (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit.
Living in the same home as the patient with a PCR test for SARS-CoV-2 Indeterminate (nasopharyngeal and/or oropharyngeal swab) performed in the Acute Respiratory Infection Diagnostic Unit and that the initial patient has positive IgM/IgG serology for SARS-CoV-2.
.Informed Consent.

Exclusion Criteria:

.Have fever, cough, pharyngeal pain or clinically have symptoms compatible with COVID-19 at the time of recruitment.
.Autoimmune disease, cancer, neutropenia.
.Under 1 years of age.
.Patients who, in the investigator's opinion, should be excluded from the research protocol.